Tag Archive: REMs

Bart’s Corner: FDA’s New REMS Guidance

In April, FDA released a final guidance on Risk Evaluation and Mitigation Strategies (REMS): Modifications & Revisions. The title is a bit of a misnomer. This is not really a modification or revision of the big issues involved with REMS creation and implementation, but rather gives guidance to companies that[…]

Read More
Bart's Corner: REMS Update

Bart’s Corner: REMS Update

In September 2014 FDA issued a paper on Standardizing & Evaluating Risk Evaluation and Mitigation Strategy (REMS). A REMS is put in place for those products to ensure that benefits outweigh the risks. REMS may require additional measures above and beyond the usual post-marketing safety surveillance by the sponsor. This[…]

Read More

Bart’s Corner: Update on EMA Risk Management Plans (RMPs)

In April of this year the EMA announced the first public summary of an RMP, in this case for the drug Neuraceq [florbetaben (18F)] The EMA also published an update of their webpage on RMPs, which noted that the revision to the Good PV Practice RMP module – Module V[…]

Read More

The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

Contact Us